To arrive at the conclusion that fraud is endemic in scientific research, Sabel and his team first looked for indicators common in fraudulent papers, including the use of an author’s private email, a non-existent hospital affiliation and an elevated number of citations from red-flagged publications. The researchers compared that data to a confirmed pool of fake papers and a sample of presumed authentic ones. Using that data, the researchers estimated the sensitivity and false alarm rates. To further bolster the accuracy of their algorithm, Sabel’s team developed an “and” rule, flagging papers as more likely to be fake if they appeared to use both a private email address and a dubious hospital affiliation. They also considered whether papers had excessive citations from red-flagged publications, which increased the algorithm’s sensitivity and lowered the false alarm rate.While not definitive proof and not yet peer reviewed, the research warrants further investigation. Renowned scientific publishers such as Elsevier, Springer and Wiley have taken steps to reduce the occurrence of biomedical research scandals. The publishing houses have worked to strengthen peer review processes to gauge research quality.
Despite the recent findings suggesting high proportions of falsified or plagiarized papers, a Drug Discovery & Development analysis of data from Retractiondatabase.org provides a somewhat contrasting perspective for the health sciences in the U.S. Rather than showing a swift acceleration in retraction numbers over the years, there is an uptick in the 2000s, but fluctuations over the past decade.
While the problem of fraud in scientific research appears to have grown in recent years — thanks in part to the proliferation of “paper mills.” These entities churn out masses of suspect scientific papers for scientists under pressure in the “publish or perish” academic culture. Here, we provide an overview of the historical context of notable scandals that have shaken the scientific community over the decades.
1960s: Unveiling bombshell biomedical research scandals
To be clear, the following two figures deserve credit for uncovering research problems in contrast to other entries in this timeline:
- Henry Beecher: The renowned Harvard Medical School anesthesiologist rocked the medical community in 1966 after publishing an article in New England Journal of Medicine, describing 22 examples of research studies that had gravely endangered their subjects. His work prompted a discussion about the need for informed consent, underscoring the need for ethical guidelines and regulations.
- Maurice Pappworth: Pappworth was pivotal in exposing unethical human experimentation in the U.K., contrasting him with most of the other figures included in this feature. His 1967 book “Human Guinea Pigs” drove major reforms in medical ethics and regulation internationally. His work helped spark a conversation around the importance of informed consent and ethical guidelines in scientific research, paving the way for stricter rules and protocols to protect human clinical trials participants. His work represented a pivotal turn in the history of biomedical research scandals.
1970s: Experimentation exaggerations
- William Summerlin: A dermatologist who fabricated research on tissue transplantation in the early 1970s. In particular, Summerlin boasted that he had transplanted skin between genetically unrelated animals by culturing the skin in a bespoke medium. After other scientists reported they couldn’t replicate his results, the scientific community learned Summerlin had painted the skin of the mice with a black marker to make it appear as if the transplants were successful.
1980s: Damaging deceits
- William McBride: The Australian obstetrician discovered the teratogenicity of thalidomide, a drug used in the 1950s and 1960s to treat morning sickness in pregnant women. But McBride helped uncover thalidomide’s role in causing birth defects, elevating his influence as a scientist. In 1982, however, McBride claimed that the drug Debendox (pyridoxine/doxylamine) also caused birth defects. A tribunal found him guilty of scientific fraud in 1993. He would ultimately lose his doctor’s license in 1995, but won it back in 1998. This scenario represents a prominent example of the stinging consequences of biomedical research scandals.
- Peter Duesberg: The molecular biologist bucked scientific consensus by claiming that HIV was not the cause of AIDS. His claims confused the public and misinformed policies on HIV.
- Robert Gallo: This American biomedical researcher was involved in uncovering HIV as the cause of AIDS. In 1992, after three years of investigations, the Federal Office of Research Integrity concluded that Gallo had committed scientific misconduct, fabricating information in a scientific paper published in 1984 on HIV.
- Baltimore affair: This scandal rocked the biomedical research community in the late 1980s and early 1990s over allegations of fabricated data in a 1986 paper published in the prestigious Cell journal. The paper was co-authored by Nobel laureate David Baltimore and Thereza Imanishi-Kari, among others. Margot O’Toole, a postdoctoral researcher, challenged core findings of the paper. Ultimately, however, an NIH panel concluded that “no evidence of fraud, conscious misrepresentation, or manipulation of data was found.’’ But the matter still left the scientific community unsettled.
- Eric Poehlman: The prominent obesity researcher DrPoehlman allegedly falsified data in a string of grant applications to NIH and other institutions from 1992 to 2000. In 2006, he was sentenced to one year in prison after getting a conviction for a single instance of grant fraud in 1999. Poehlman also acknowledged falsifying 17 grant applications to NIH and fabricating data in 10 of his papers. His conviction led to stricter controls and oversight in the funding process.
- Werner Bezwoda: The South African oncologist fabricated data in clinical trials of high-dose chemotherapy in breast cancer patients in the 1990s. Other researchers were unable to replicate his claimed high survival rates, leading to more scrutiny of his research. In 2001, Bezwoda admitted to inventing data related to more than 400 patients in studies published in major journals like the New England Journal of Medicine, leading medical journals to enact stricter review policies.
- John Darsee: A cardiologist at Harvard Medical School was found guilty of fabricating large amounts of data in his research studies. An NIH review uncovered “wide-ranging scientific misconduct,” concluding that Darsee fabricated data from fictional experiments. Consequently, NIH banned him from funding for 10 years.
- Andrew Wakefield: The former British physician played a role in catapulting the anti-vaxxer movement by publishing a fraudulent study in 1998 tying the measles, mumps, rubella (MMR) vaccine to autism. Although the study was retracted and Wakefield lost his medical license, the paper would play a role in exacerbating vaccine phobia, whose origins stretch back to centuries.
- Hwang Woo-suk: This South Korean scientist claimed to have created the first human embryonic stem cells by cloning in 2004. Later investigations revealed that he had fabricated parts of his research. The scandal set back the field of stem cell research and undermined public confidence in the research.
- Elizabeth Holmes and Theranos: Though not directly related to drug development, this scandal was a significant event in the life sciences industry. In 2013, investors valued Theranos at $13 billion. Holmes was ultimately sentenced to 11 years in prison in 2022.
- Bharat Aggarwal: This researcher at the University of Texas M.D. Anderson Cancer center published a suspicious study suggesting curcumin can destroy cancer cells. His work attracted an investigation in 2012 over alleged falsification of data related to cancer-fighting plant-derived chemicals. By 2022, publishers had retracted 30 of his research papers. Several others had received expressions of concern or have been corrected.
- Anna Ahimastos: This medical researcher at the Baker IDI Heart and Diabetes Institute in Melbourne, Australia fabricated data in a study of the blood pressure drug ramipril. She later acknowledged fabricating records for some patients. Researchers discovered the misconduct in 2015.
- Yoshitaka Fujii: This Japanese anesthesiologist appears to have fabricated roughly 172 studies over a two-decade period. An investigational panel could find no records of patients in the studies.”It is as if someone sat at a desk and wrote a novel about a research idea,” surmised the Japanese Society of Anaesthesiologists investigating committee. Scientists uncovered the misconduct in 2012.
- Paolo Macchiarini: The Italian surgeon became famous after claiming to have pioneered a synthetic trachea transplant procedure using stem cells. Later, it became evident that several patients who underwent the procedure died. An independent review in 2016 found fault in three synthetic trachea operations at Karolinska University Hospital. In 2022, a Swedish court handed Marcciarini a suspended sentence for causing bodily harm in a transplant procedure.
- Surgisphere scandal: An eventually retracted medical study claimed that the antimalarial drug hydroxychloroquine increased death risks in COVID-19 patients. The study stoked controversy over the medication, which public figures such as former President Donald Trump had baked. The research, published in The Lancet and the NEJM, relied on data from the healthcare analytics company Surgisphere. The study raised eyebrows in the scientific community, which eventually spotted suspect case numbers and other data discrepancies.
- Predatory journals: The rise of so-called predatory journals, which tend to lack rigorous peer review and exploit the open-access model, poses a threat to the integrity of scientific research. A review in 2018 published in the Annals of Global Health provided an overview of the problem.
- Yoshinori Watanabe: A highly regarded cell biologist, Watanabe was found to have manipulated images in multiple papers. A 2018 investigation by the University of Tokyo concluded that he was guilty of misconduct, leading to several retractions. The case highlighted the vulnerability of image-based data to manipulation.
- He Jiankui: The Chinese researcher who claimed to have produced genetically edited babies in 2018 was sentenced in 2019 to three years in prison for “illegal medical practices.” A court found He, plus two collaborators, guilty of forging ethical review documents and deceiving doctors into implanting gene-edited embryos into two women.
2020–present: Pandemic pseudoscience and other biomedical research scandals
- Dubious ivermectin research: During the pandemic, there were instances of suspect research testing the potential of the anti-parasitic drug ivermectin as a COVID-19 therapy. One seemingly promising ivermectin study featuring a meta-analysis had data from 11 patients who were cloned to appear like a data set of a few hundred.
- COVID-19 vaccine development questions: The swift development of multiple COVID-19 vaccines was a landmark scientific achievement, but the speed also contributed to some instances of data misinterpretation. For instance, it was initially difficult to understand the efficacy of the AstraZeneca-Oxford vaccine (ChAdOx1 nCoV-19), given different efficacy rates reported for different dosage regimens (standard dose/standard dose and low dose/standard dose cohorts).
- Hydroxychloroquine controversy: During the early stages of the COVID-19 pandemic, conflicting reports emerged about the effectiveness of the drug hydroxychloroquine as a potential treatment for SARS-CoV-2 infection. Publishers of some of those studies later retracted them. A Nature meta-analysis found the drug combined with the standard of care to have no additional benefit in hospitalized COVID-19 patients and a higher rate of adverse events.
- Leen Kawas: Resigned as CEO of Athira in 2021 following an investigation into her doctoral work, underscoring the need for rigorous academic integrity checks at all career levels. The incident is but one example of a growing number of scientific articles that have been called into quotations over image manipulation.
- Ching-Shih Chen: A prominent cancer researcher at Ohio State University, resigned in 2018 after an investigation found him guilty of image manipulation in several published studies. The university published its findings online. In 2010, it had named Chan innovator of the year for his oncology research.
- Naoki Mori: A prominent Japanese oncology researcher had more than 30 papers retracted as a result of image manipulation allegations. The retractions followed an investigation from the University of the Ryukyus in Okinawa, Japan, where Mori worked. In 2017, an investigation from the University of Tokyo concluded that he manipulated images in five published research papers.
- Aducanumab controversy: Biogen’s Alzheimer’s drug was the first to win FDA approval in years, but backlash swiftly followed. Critics alleged that clinical trials used to approve the drug were ambiguous and accused FDA and Biogen of entering into an inappropriate relationship ahead of its approval. Several members of the independent advisory committed who advised on the agency ahead of the approval resigned.
- AI and machine learning in research: The growing use of artificial intelligence in scientific research offers both perils and promise in the arena of data integrity. While such tools can accelerate research, they are not without shortcomings. Problematic areas include biased training data and synthetic biases as well, as NIST has noted. A study published in JAMA concluded that machine learning algorithms used in healthcare are frequently trained on data that disproportionately comes from a handful of states, such as California, New York and Massachusetts. That problem could drive systemic biases in these algorithms, the authors conclude. Additionally, the prospect of AI-generated deepfake images could lead to future biomedical research scandals as image manipulation is already a significant problem.
Filed Under: clinical trials, Data science, Drug Discovery, machine learning and AI, Regulatory affairs
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